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临床试验/NCT07108517
NCT07108517招募中不适用

A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth. The Overarching Aim of IC-Growth is to Promote Psychosocial Care and Support for People With Cancer Using Acceptance and Committment Therapy.

Centre for Research and Technology Hellas1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Post-Traumatic Growth (PTG)

研究概览

简要总结

Cancer can be a very traumatic experience for the people affected and the majority of the psychological literature focuses on this. Less proliferated and researched is the increasingly recognized fact that as a result of struggling with such traumatic adversities, some people experience what is known as post-traumatic growth (PTG). PTG not only allows them to overcome their trauma (e.g., impact of cancer) and return to pre-diagnosis functioning (e.g., health, wellbeing, employment) but also results in them going over and above their previous state (e.g., increased resilience). This renders PTG an important phenomenon that could be enhanced as part of the support people with cancer receive. IC-Growth has two interconnected paths, namely a research one and another of health policy and best practice recommendations. On the first path, is a sequence of three studies, starting with a systematic review, followed by a cross-sectional study and concludes with a randomized control trial (RCT). The systematic review and close collaboration with experts (e.g., patient associations) will lead to the development of a novel manual to facilitate PTG in groups of people with cancer. The cross-sectional study will explore relationships between variables (e.g., PTG, quality of life, biological variables, illness perceptions, distress, anxiety, depression) in people with cancer (n = 150-180). Lastly, the RCT will evaluate the intervention's effects among three different groups (breast, colorectal, and head and neck cancers, n = 50-60 per group). On the other path, is the development of health policy and best practice recommendations regarding the psychosocial support of people with cancer in Greece. The project's results will be disseminated to stakeholders who provide support to people with cancer (e.g., oncologists, surgeons, psychologists, psychiatrists), through professional associations, a conference on "Psychosocial Support in Oncology", and publications in scientific journals. Overall, IC-Growth is a multidisciplinary project (i.e., psychology, medical, patient organizations, health policy) and joins the clinical, research and policy fields together to workable actions leading to empowering the wider community of people with cancer and improving their care.

详细描述

Detailed Description IC-Growth is a 24-month, multidisciplinary research and clinical project aimed at enhancing psychosocial care for adults with cancer by promoting post-traumatic growth (PTG)-positive psychological changes following traumatic life crises. While most research emphasizes the negative psychological effects of cancer, IC-Growth focuses on understanding and facilitating PTG as a mechanism to improve well-being, resilience, and quality of life (QoL) beyond pre-diagnosis levels.

The project has two interconnected components:

Research - A sequence of three studies to build, test, and evaluate a novel, manualized PTG intervention for cancer patients:

A systematic review (using PRISMA 2020 and Cochrane standards) to synthesize evidence on PTG interventions.

A cross-sectional study (n = 210-240; breast, colorectal, and head & neck cancer) to examine associations among PTG, QoL, biological markers (e.g., cortisol), illness perceptions, distress, anxiety, and depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥ 18 years)
  • •Having a diagnosis of a. Breast Cancer, b. Colorectal Cancer, or c. Head and Neck Cancer.
  • •Having concluded the planned chemotherapy courses and related hospital admissions
  • •Having no more than 5 years since the initial diagnosis.

排除标准

  • •Being in active psychological or psychiatric treatment
  • •Having an unmanaged mental health difficulty
  • •Having a severe cognitive impairment
  • •Being unable to give informed consent
  • •Being unable to speak or read Greek
  • •Having one or more relapses
  • •Diagnosed with another type of cancer within 5 years prior to recruitment.
  • •Having less than one-year life expectancy

研究组 & 干预措施

1. Group-Based Post-Traumatic Growth (PTG) Intervention

Experimental

Participants receive a manualized, group-based psychosocial intervention designed to enhance post-traumatic growth (PTG). The program is delivered over 6-8 weeks, with weekly 90-minute sessions, and incorporates evidence-based techniques (e.g., Acceptance and Commitment Therapy, mindfulness, cognitive and narrative exercises, and interpersonal support).

干预措施: IC-Growth ACT-Based Support Program (Behavioral)

2. Standard Care (Usual Oncology Follow-Up)

No Intervention

Participants receive standard oncology follow-up care with no additional psychosocial intervention. They will complete the same assessments as the intervention group at baseline and post-intervention.

结局指标

主要结局

Post-Traumatic Growth (PTG)

时间窗: Baseline and post-intervention (6-8 weeks)

PTG will be assessed using the Post-Traumatic Growth Inventory (PTGI), a validated 21-item self-report questionnaire measuring positive psychological change following trauma. Higher scores indicate greater post-traumatic growth.

次要结局

  • Anxiety and Depression(Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item validated self-report tool. Higher scores indicate greater levels of anxiety and depression.)
  • Quality of Life and Spiritual Well-being(Baseline and post-intervention (6-8 weeks))
  • Distress Related to Traumatic Events(Baseline and post-intervention (6-8 weeks))
  • Illness Perceptions(Baseline and post-intervention (6-8 weeks))
  • Salivary Cortisol Levels(Baseline and post-intervention (6-8 weeks))

研究者

发起方
Centre for Research and Technology Hellas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Karamanidou

Health Psychologist, Researcher, PhD

Centre for Research and Technology Hellas

研究点 (1)

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